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Ziftomenib with Venetoclax and Gemtuzumab Ozogamicin for the Treatment of Pediatric Patients with Relapsed or Refractory Acute Myeloid Leukemia or Mixed Phenotype Acute Leukemia

Trial Status: active

This phase I trial tests the safety, side effects and best dose of ziftomenib with venetoclax and gemtuzumab ozogamicin for the treatment of pediatric patients with acute myeloid leukemia (AML) or mixed phenotype acute leukemia (MPAL) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Ziftomenib is in a class of medications called menin inhibitors. It works by blocking the action of proteins that signal cancer cells to multiply, which may help keep cancer cells from growing. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Gemtuzumab ozogamicin is a monoclonal antibody, called gemtuzumab, linked to an antitumor antibiotic drug, called calicheamicin. Gemtuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD33 receptors, and delivers calicheamicin to kill them. Giving ziftomenib with venetoclax and gemtuzumab ozogamicin may be safe and tolerable in treating pediatric patients with relapsed or refractory AML or MPAL.